Non-Inferiority Trial of Trauma Informed Guilt Reduction Therapy (TrIGR) for PTSD

创伤知情内疚减轻疗法 (TrIGR) 治疗 PTSD 的非劣效性试验

• 批准号: 10584430
• 负责人: SONYA NORMAN
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10584430
• 关键词: Afghanistan; Aftercare; Clinic; Clinical; Cognitive; Diagnosis; Disease; Distress; Dropout; Emotions; Enrollment; Exclusion Criteria; Feeling suicidal; Guilt; Healthcare Systems; Impairment; Intervention; Iraq; Learning; Mediating; Mental Depression; Mental Health; Mental Health Services; Outcome; Persons; Phase; Post-Traumatic Stress Disorders; Protocols documentation; Psychopathology; Randomized; Reporting; Resources; Role; Severities; Shame; Site; Supportive care; Survivors; Symptoms; Trauma; Treatment outcome; United States Department of Veterans Affairs; Veterans; Veterans Health Administration; Work; arm; brief intervention; cost; depressive symptoms; efficacy study; evidence base; experience; improved; psychosocial; randomized, clinical trials; reduce symptoms; response; suicidal risk; trauma exposure; traumatic event

Trauma-related guilt is common and impairing among trauma survivors, particularly among treatment seeking Veterans with posttraumatic stress disorder (PTSD). Guilt is a distressing emotion that arises when trauma survivors blame themselves for the outcome of a traumatic event and guilt turns to shame when people judge not just their actions but themselves negatively because of what happened. Guilt is positively associated with severity of PTSD and depression symptoms, suicidal ideation, poorer psychosocial functioning, and shame. Among those with PTSD, guilt is one of the symptoms likely to persist after PTSD treatment, suggesting further intervention targeting guilt is needed. Although evidence-based trauma-focused PTSD treatments such as Cognitive Processing Therapy (CPT) are effective to treat PTSD and trauma-related guilt, many still experience symptoms or maintain their diagnosis after treatment, and dropout from these generally 12+ session protocols is high. Veterans show lower response and higher dropout than others with PTSD. Delivering protocols that are generally 12 or more sessions challenges the Veterans Affairs (VA) healthcare system given high demand for mental health care. For these reasons, additional and less burdensome approaches are needed. Brief treatment that targets mechanisms that are distressing and associated with multiple problems and disorders may be an understudied but promising way to treat PTSD and other posttraumatic psychopathology. Our work shows that a brief treatment targeting trauma-related guilt and shame, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt, PTSD, depression, and distress among Veterans and help them reengage with activities they find meaningful. In a preliminary efficacy study with 144 OEF/OIF/OND Veterans with guilt from a deployment trauma, we found large effects in PTSD symptom reduction and moderate effects in depression symptom reduction in TrIGR compared to supportive therapy. More than 50% lost their PTSD diagnosis and two thirds showed clinically meaningful change. Dropout was low and attendance was high - Veterans attended more than five of six sessions on average. Whether TrIGR is no less effective than longer, more resource heavy evidence-based PTSD treatments disseminated across by VA, like CPT, is the next critical question. The proposed randomized clinical trial (RCT) will be the first non-inferiority trial of TrIGR and the first to compare TrIGR to a first tier PTSD treatment, specifically CPT. It will also be the first to evaluate TrIGR with Veterans from all eras with guilt from any type of traumas, as our previous work was exclusively with Veterans of the conflicts in Iraq and Afghanistan with deployment-related traumas. 158 Veterans across two VA sites will be randomized to TrIGR or CPT. Exclusion criteria will be minimal so that generalizability will be high. Treatment will be delivered in VA mental health clinics. The primary aim is to evaluate if TrIGR is non-inferior to CPT in reducing PTSD symptom severity among Veterans with PTSD who endorse trauma-related guilt. Secondary aims are to evaluate TrIGR’s non-inferiority relative to CPT regarding depression severity. We will explore potential mechanisms of treatment, such as the relationship between change in guilt and shame change in PTSD symptoms and the role of inhibitory learning in treatment outcomes. We will also examine differential dropout and change in suicidal ideation and psychosocial functioning. The proposed study is critical to establish whether TrIGR is effective for a much larger group of Veterans and whether it is as effective as longer treatments already available in VA to inform if TrIGR warrants further study and dissemination in VA.

与创伤有关的内疚感在创伤幸存者中很常见，特别是在寻求治疗的人群中 患有创伤后应激障碍的退伍军人。内疚是一种痛苦的情绪， 幸存者为创伤事件的结果而自责，当人们评判时， 不仅是他们的行为，而且是他们自己因为所发生的事情而产生的负面影响。内疚感与 PTSD和抑郁症状的严重程度、自杀意念、较差的心理社会功能和羞耻感。 在PTSD患者中，内疚感是PTSD治疗后可能持续存在的症状之一，这表明进一步的治疗可能会导致创伤后应激障碍。 需要针对内疚进行干预。 虽然以证据为基础的创伤为中心的PTSD治疗，如认知加工疗法（CPT）， 有效治疗创伤后应激障碍和创伤相关的内疚，许多人仍然经历症状或维持诊断 在治疗后，这些通常为12+疗程的方案的退出率很高。退伍军人显示较低 与其他PTSD患者相比，反应和辍学率更高。提供通常为12个或更多的协议 会议挑战退伍军人事务部（VA）的医疗保健系统，因为对精神卫生保健的需求很高。 出于这些原因，需要采取额外的、负担较轻的办法。针对性的短期治疗 令人痛苦的和与多种问题和障碍相关的机制可能是一个未充分研究的问题。 但很有希望治疗创伤后应激障碍和其他创伤后精神病理学。我们的研究表明， 针对创伤相关的内疚和羞耻的治疗，创伤知情内疚减少疗法（TrIGR），可以 减少退伍军人的内疚感、创伤后应激障碍、抑郁和痛苦，帮助他们重新参与他们发现的活动。 有意义的在一项初步疗效研究中，144名OEF/OIF/OND退伍军人因部署而感到内疚， 创伤后，我们发现在PTSD症状减轻方面有很大的效果，在抑郁症状方面有中等的效果 与支持性治疗相比，TrIGR降低。超过50%的人失去了他们的PTSD诊断，三分之二的人 出现了有临床意义的变化。辍学率低，出勤率高-退伍军人参加更多 平均六次治疗中的五次以上。TrIGR的有效性是否不低于时间更长、资源更重的 下一个关键问题是由退伍军人事务部传播的基于证据的创伤后应激障碍治疗，如CPT。 拟议的随机临床试验（RCT）将是TrIGR的第一个非劣效性试验，也是第一个 将TrIGR与第一层PTSD治疗进行比较，特别是CPT。它也将是第一个评估TrIGR的公司， 退伍军人从任何类型的创伤内疚的所有时代，因为我们以前的工作是专门与退伍军人 在伊拉克和阿富汗的冲突与部署相关的创伤。两个VA站点的158名退伍军人将 随机分配至TrIGR或CPT。排除标准将是最低限度的，因此普遍性将是高的。 治疗将在VA心理健康诊所提供。主要目的是评价TrIGR是否非劣效于 CPT在减少PTSD退伍军人中的PTSD症状严重程度，这些退伍军人支持创伤相关的内疚。 次要目的是评价TrIGR在抑郁严重程度方面相对于CPT的非劣效性。我们将 探索潜在的治疗机制，例如内疚和羞耻之间的关系 PTSD症状的改变和抑制性学习在治疗结果中的作用。我们亦会研究 差异辍学和自杀意念和心理社会功能的变化。拟议的研究至关重要 确定TrIGR是否对更大的退伍军人群体有效，以及它是否与 VA中已有更长的治疗，以告知TrIGR是否需要在VA中进行进一步研究和传播。